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α 受体阻滞剂联合米拉贝隆与 α 受体阻滞剂联合抗胆碱能药物治疗良性前列腺增生伴膀胱过度活动症患者下尿路症状的安全性和有效性:系统评价和网络荟萃分析。

Safety and efficacy of an α -blocker plus mirabegron compared with an α -blocker plus antimuscarinic in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia and overactive bladder: A systematic review and network meta-analysis.

机构信息

Department of Surgery/Urology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.

Department of Urology, School of Medicine, Marmara University, Istanbul, Turkey.

出版信息

Neurourol Urodyn. 2024 Mar;43(3):604-619. doi: 10.1002/nau.25399. Epub 2024 Jan 30.

Abstract

AIM

Antimuscarinics and the β3-adrenoreceptor agonist, mirabegron, are commonly used for treating patients with overactive bladder (OAB) and α -adrenoreceptor antagonists (α -blockers) are the main pharmacological agents used for treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). As these conditions commonly occur together, the aim of this systematic review was to identify publications that compared the use of an α -blocker plus mirabegron with an α -blocker plus antimuscarinic in men with LUTS secondary to BPH and OAB. A meta-analysis was subsequently conducted to explore the safety and efficacy of these combinations.

METHODS

Included records had to be from a parallel-group, randomized clinical trial that was ≥8 weeks in duration. Participants were male with LUTS secondary to BPH and OAB. The indirect analyses that were identified compared an α -blocker plus OAB agent with an α -blocker plus placebo. The PubMed/Medical Literature Analysis and Retrieval System Online, the Excerpta Medica Database, the Cochrane Central Register of Controlled Trials, and the ClinicalTrials.gov registry were searched for relevant records up until March 5, 2020. Safety outcomes included incidences of overall treatment-emergent adverse events (TEAEs) and urinary retention, postvoid residual volume, and maximum urinary flow (Q ). Primary efficacy outcomes were micturitions/day, incontinence episodes/day, and urgency episodes/day, and secondary outcomes were Overactive Bladder Symptom Score and International Prostate Symptom Score. A Bayesian network meta-analysis approach was used for the meta-analysis.

RESULTS

Out of a total of 1039 records identified, 24 were eligible for inclusion in the meta-analysis. There were no statistically significant differences between the α -blocker plus mirabegron and α -blocker plus antimuscarinic groups in terms of the comparisons identified for all the safety and efficacy analyses conducted. Numerically superior results were frequently observed for the α -blocker plus mirabegron group compared with the α -blocker plus antimuscarinic group for the safety parameters, including TEAEs, urinary retention, and Q . For some of the efficacy parameters, most notably micturitions/day, numerically superior results were noted for the α -blocker plus antimuscarinic group. Inconsistency in reporting and study variability were noted in the included records, which hindered data interpretation.

CONCLUSION

This systematic review and meta-analysis showed that an α -blocker plus mirabegron and an α -blocker plus antimuscarinic have similar safety and efficacy profiles in male patients with LUTS secondary to BPH and OAB. Patients may, therefore, benefit from the use of either combination within the clinical setting.

摘要

目的

抗毒蕈碱药物和 β3-肾上腺素受体激动剂米拉贝隆常用于治疗膀胱过度活动症(OAB)患者,而 α-肾上腺素受体拮抗剂(α-阻滞剂)是治疗良性前列腺增生(BPH)引起的下尿路症状(LUTS)的主要药物。由于这些病症通常同时存在,因此本系统评价的目的是确定比较 α-阻滞剂加米拉贝隆与 α-阻滞剂加抗毒蕈碱药物治疗 BPH 和 OAB 继发 LUTS 男性患者的出版物。随后进行了荟萃分析,以探讨这些组合的安全性和疗效。

方法

纳入的记录必须来自持续时间至少为 8 周的平行组随机临床试验。参与者为患有 BPH 和 OAB 继发 LUTS 的男性。确定的间接分析比较了 α-阻滞剂加 OAB 药物与 α-阻滞剂加安慰剂。直到 2020 年 3 月 5 日,检索了 PubMed/医学文献分析和检索系统在线、Excerpta Medica 数据库、Cochrane 对照试验中心注册库和 ClinicalTrials.gov 注册库,以查找相关记录。安全性结果包括总体治疗中出现的不良事件(TEAEs)和尿潴留、残余尿量和最大尿流率(Q )的发生率。主要疗效结局为每日排尿次数、失禁发作次数和尿急发作次数,次要结局为膀胱过度活动症症状评分和国际前列腺症状评分。使用贝叶斯网络荟萃分析方法进行荟萃分析。

结果

在总共确定的 1039 条记录中,有 24 条符合纳入荟萃分析的标准。在进行的所有安全性和疗效分析中,α-阻滞剂加米拉贝隆组与 α-阻滞剂加抗毒蕈碱药物组之间在所有确定的比较中均无统计学差异。与 α-阻滞剂加抗毒蕈碱药物组相比,α-阻滞剂加米拉贝隆组在安全性参数(包括 TEAEs、尿潴留和 Q )方面通常观察到更好的数值结果。在一些疗效参数方面,尤其是每日排尿次数,α-阻滞剂加抗毒蕈碱药物组的数值结果更好。纳入的记录中注意到报告不一致和研究变异性,这阻碍了数据解释。

结论

本系统评价和荟萃分析表明,α-阻滞剂加米拉贝隆和 α-阻滞剂加抗毒蕈碱药物在患有 BPH 和 OAB 继发 LUTS 的男性患者中具有相似的安全性和疗效特征。因此,患者可能会受益于在临床环境中使用这两种组合。

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